The document outlines the WHO guidelines for the quality control and standardization of herbal drugs, emphasizing the importance of consistency, safety, and efficacy. It details various parameters for testing herbal medicine quality, including chemical fingerprinting, physicochemical analysis, and toxicological assessments. Additionally, it mentions methods for monitoring microbial contamination and the use of irradiation to ensure safety.

1. Quality Control & Standardization
Of Herbals
WHO Guidelines For Quality Control Of
Herbal Drugs
By
Kaushal Kumar

2. Tabel Of Contents
01 02 03 04
Introduction Monograph Parameter Type

3. Quality control of herbal medicines aims
to ensure their consistency, safety and
efficacy.
Chemical fingerprinting has been
demonstrated to be a powerful technique
for the quality control of herbal medicines.
Introduction

4. For the purpose of quality control of herbal drugs, the World Health Organization (WHO)
has prepared the guidelines. The objective of the guidelines involves general test methods
and also the general limits for contaminants in herbal drugs. A typical monograph for herbal
drugs as per WHO Guidelines is as follows:
Monograph for Herbal Drugs as per WHO Guidelines
Introduction
Monograph Title Parameters Types
Botanical
Sensory Evaluation Visual/ Macroscopy/ Touch/
Taste/ Odour/ Size/ Colour
Foreign Matter Foreign plants, animals, minerals
(soil, stones, sand and dust)
Microscopy Histological observation,detection,
measurement of specimens, etc.

5. Introduction
Monograph Title Parameters Types
Physicochemical
TLC Ascending technique, horizontal
technique, etc.
Ash Total, acid insoluble, water-soluble
Microscopy Histological observation,detection,
measurement of specimens, etc.
Extractable matter Hot water, cold water and ethanol
Water content
and volatile
Matter
LOD, Azeotropic
Volatile oils By steam distillation

6. Monograph Title Parameters Types
Pharmacological
Bitterness value Units Ex- To the bitterness of
standard solution of Quinine
hydrochloride
Haemolytic Activity On Ox blood by comparison
with standard saponin
Astringency Fraction (Tannins) that binds to
standard hide powder
Swelling Index In water
Foaming Index Foam height produced by 1 gm
material under specified
conditions
Monograph

7. Monograph
Monograph Title Parameters Types
Toxicological
Pesticide residue Total organic chloride and total
organic
Phosphorus
Arsenic Stain produced on HgBr2
paper in comparison to
standard stain
Heavy metals Cadmium and Lead
Microbial Contamination
Aerobic count pathogen Enterobacteriaceae -
Escherichia coli, Salmonella,
Staphylococcus,
Pseudomonas
Aflatoxins TLC using standard Aflatoxins
(B;, Bz, G;, G2) mixture

8. Monograph
Monograph Title Parameters Types
Radioactive
contamination
Microbial growth in herbals can be avoided by irradiation.
Nature
and the intensity of irradiation depend on the source. The
radioactivity of the plant samples should be checked
according to
the guidelines of the International Atomic Energy Agency
(IAEA),
Vienna, Austria.

9. THANKS!
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